BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPOUCH SPEC BAG

    MDR report key: 2182954 · Received July 28, 2011

    Report

    Report Number
    3005075853-2011-03066
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 10, 2011
    Report Date
    July 13, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K011501
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED WITH THE PUSH PULL ROD BROKEN AT HANDLE ASSEMBLY AREA; MAKING THE INSTRUMENT NON-FUNCTIONAL. POSSIBLE CAUSE OF THE FINDING IS THE APPLICATION OF EXTERNAL EXCESSIVE FORCE OVER THE DEVICE THAT CAUSES THE PUSH PULL ROD BECOME BROKEN DURING TRANSIT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY PROCEDURE, IN OPENING THE PACKAGE, THE POUCH WAS BROKEN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPOUCH SPEC BAG LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA H43H19

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR